Home / Recalls / Medical Devices
ROUTE 92 MEDICAL INC recalls Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev
Recalled May 1, 2024 · FDA recall Z-1610-2024 · ROUTE 92 MEDICAL
Hazard
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters. · FDA Class I
Units
10 units
Sold at
US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
Description
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Product
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Manufacturer(s)
ROUTE 92 MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →